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Generics pose new threat in addiction fight

Published on NewsOK Modified: December 16, 2012 at 10:41 am •  Published: December 16, 2012

LOUISVILLE, Ky. (AP) — Kentucky's struggle to curtail prescription-pill abuse will suffer a setback if a wave of generic versions of painkillers reaches the market without safeguards that make them harder to crush for a quick high, political and law-enforcement leaders said.

Patents for OxyContin and Opana ER — opioid pain relievers used to treat moderate to severe pain — are set to expire next year, paving the way for generic versions of those powerful medications to reach pharmacies. Those brand-name drugs were popular sources with abusers until tamper-resistant formulations were added that made them harder to crush — a practice used by abusers to inject or snort the drugs.

Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people already taking pain medications, including cancer patients, to treat severe pain flare-ups.

The fear now is that cheaper generic versions of those often-prescribed painkillers won't feature some form of abuse deterrence. Without that, they could become the new drugs of choice for abusers in a state where more people die from drug overdoses than car wrecks.

"We are running perilously close to another potential pain pill cliff," U.S. Rep. Harold "Hal" Rogers wrote in a recent opinion piece.

There are limited versions of generic painkillers on the market now and more generics are expected to be introduced in the coming year. Most of the generic painkillers don't have such safeguards. The concern among Kentucky officials is that sales of the cheaper generic versions lacking the anti-abuse features will overtake the brand name drugs with the safeguards.

Rogers and his fellow Kentucky Republican, Senate Minority Leader Mitch McConnell, are pressing the Food and Drug Administration to prevent "crushable" forms of those generic painkillers from pouring into Kentucky next year.

Rogers, whose Appalachian district has been plagued by prescription abuse, said introduction of easily crushable generics would be "downright disastrous," jeopardizing painstaking gains made in the fight against abuse of drugs found in family medicine cabinets.

"We know the storm's coming," said Clay County Sheriff Kevin Johnson. "We're sitting here trying to prepare for the hurricane."

Prescription-pill abuse remains rampant in his eastern Kentucky county, he said. The craving for pills fuels crimes — people breaking into homes to rummage through medicine cabinets and steal electronics to generate cash to obtain painkillers, the sheriff said.

"Our biggest problem here is without a doubt the controlling of prescription drugs, plain and simple," he said.

The Generic Pharmaceutical Association, an industry trade group, defends its role as a supplier of "lifesaving, affordable" medicines.

"Generic manufacturers comply fully with all FDA requirements and are committed to working with the agency to ensure the safety and quality of the medicines they make," the group said in a statement.

Kentucky lawmakers took aim at prescription-abuse woes by passing legislation this year that bolstered the state's prescription monitoring system and focused on pain management clinics. The law requires all new pain management clinics to be owned by licensed medical providers and to have medical directors in charge. It also requires all doctors, dentists, optometrists, registered nurses and podiatrists who write prescriptions to use the state's prescription monitoring system, known as KASPER.

Gov. Steve Beshear has touted the new law's impact in efforts to reverse the state's status as a "prescription playground." He has pointed to a big drop in the amount of painkillers being prescribed and the closure of 10 pain management clinics.

The law has not impeded the ability of patients to obtain medications for "legitimate pain," the governor has said.

Pain relievers such as OxyContin and Opana ER feature extended-release formulations designed to give long-lasting effects. The problem is that when crushed, those drugs deliver hours' worth of pain relief in a matter of seconds when injected or snorted, said state Attorney General Jack Conway. He's among officials who fear an influx of easily crushable generic pain medication will result in more overdose deaths.

The FDA hasn't ruled on whether the abuse-deterrent features should be required on the generic versions.

McConnell, in a recent letter to FDA Commissioner Margaret Hamburg, asked if there's a precedent for removing a generic drug from the market that lacks a safety mechanism included as part of the brand-name drug.

The senator also asked what steps could be taken for FDA approval of the same generic drugs to include tamper-resistant formulation.

The agency was preparing a response to McConnell's letter, said FDA spokeswoman Morgan Liscinsky. She said the agency also is reviewing citizen's petitions asking it to require abuse-deterrent forms of such opioid pain relievers when those features are available.

"The FDA understands how important it is to give guidance and appropriate support regarding the development of abuse-deterrent formulations of opioids, and also recognizes the important role that generic drugs play in our health-care system," she said in an email.

Johnson, the eastern Kentucky sheriff, said the FDA "needs to take the bull by the horns" to avoid the influx of crushable generics.

"We can arrest drug addicts all day long, but that's not solving the problem," he said.

Rogers, who wields considerable influence as chairman of the House Appropriations Committee, is a leading sponsor of federal legislation that would require most pain drugs to adopt abuse-deterring safeguards.

The congressman said inaction by FDA will shrivel demand for more expensive pain medication featuring abuse safeguards, in favor of cheaper generics that are easily crushable.

The result, he said, is "we will be right back where we were 10 years ago with pharmacy robberies, drive thru pain clinics, orphaned children and overcrowded emergency rooms. The clock is ticking and this health crisis has a partial solution, but failure to intervene by FDA will mean it has failed its basic mission."


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